Diagnostic instrument



Jan. 22, 1963 K s MacLEAN DIAGNOSTIC INSTRUMENT K. S. MaCLEAN Jan. 22, 1963 DIAGNOSTIC INSTRUMENT 3 Sheets-Sheet 2 Filed April 16, 1959 A TTOIVEYS K. S. MaCLEAN Jan. 22, 1963 DIAGNOSTIC INSTRUMENT 3 Sheets-Sheet 3 Filed April 16, 1959 INVENTOR. /ff/V/VETH S. /V/ic EA/V United States Sdhti Patented dan. 22, 1963 dce This invention relates to a structurally and functionally improved diagnostic instrument, and more particularly an instrument by means of which specimens of cells may be readily collected from internal body tissues and subsequently examined with a View toward especially determining if a condition of cancer prevails.

An obj-ect of this invention is to furnish a relatively simple and improved apparatus which may be readily manipulated by a physician with assurance that an adequate cell specimen from the desired body site will be rendered available in order that denite conclusions may be reached as a result of his findings; and in addition, the utilization of such apparatus most advantageously involves an uncomplicated technique requiring the expenditure of only a minimum amount of time Without substantial discomfort on the part of the patient.

Another object is to provide an apparatus capable of collecting cell specimens from internal body sites and, at the same time, incorporate means for aspirating and dilating body passages so that the apparatus may be more effectively manipulated therein.

Still another object is that of furnishing for employment in an instrument assembly of this character a cellcollecting element which may be of the disposable type such that after the cell specimens have been collected the element may be discarded.

A further object is that of furnishing for employment in an instrument assembly of the above character a cellcollecting element which possesses expansible properties rendering it possible to expand this element by such an instrument assembly which possesses suitable means for accomplishing such purposes.

An additional object is that of providing an assembly of parts, each individually simple, rugged in construction and capable of ready manufacture, and a unitary assembled mechanism capable of operating over long periods of time with freedom from all diihculties.

Other objects and advantages will become apparent from the following description which is to Vbe taken in conjunction with the accompanying drawings illustrating practical embodiments of the present invention, and in which:

FIG. l is an elevational view of one form of instrument incorporating the teachings of the present invention with a cell-collecting mandrel assembly in a projected position;

FlG. 2 is an enlarged longitudinal sectional view of the rear of an actuator assembly incorporated into the present invention;

FlG. 3 is an enlarged longitudinal sectional view of the forward part of this actuator assembly;

FIG. 4 is an enlarged sectional view taken along the line 4 4 of FiG. 1, with a distensible core member included in the mandrel assembly;

FIG. 5 is an elevational View similar to FIG. 1, showinfy certain parts in a disassembled condition and with the cell-collecting mandrel assembly in a retracted position within a guiding tube or shield which has a capsule (in phantom) closing the opening at its free end;

FG. 6 is an elevational View of the foregoing instrument which has coupled therewith an expansible cellcollecting element;

FIG. 7 is an enlarged sectional View taken along the line '7-7 of PEG. 6;

FIG. 8 is an elevational View of another embodiment of this invention in which a further form of cell-collecting element is attached to the foregoing instrument;

FIG. 9 is an enlarged and fragmentary sectional View of a cell-collecting element in the form of a brush in which the bristles are beveled to facilitate the collection of cells from a -body tissue.

In the drawings, the numeral 12 indicates a tubular sheath fabricated from a resilient and flexible type of resinous material. This sheath 12 functions as a shield for the probing or cell-collecting element to be described shortly, and may include, at one of its ends, an annularly anged ring member (not shown) for supplying the necessary rigidity for maintaining the opening at this end. The other end of sheath 12 is coupled to a T 16 of an actuator assembly 18. This T 16 has a longitudinally extending bore 20 normally communicating with the passage of the sheath 12 and bore 22 of the T stem 24, which is in the form of a conically-shaped nipple having serrations, threads or the like for facilitating its connection with a pressure dilferential source (not shown) for aspiration or dilation purposes. The T 16 additionally includes a reduced boss 26' for mounting the associated end of sheath 12. The T 16 has an externally threaded portion 28 which, together with a similarly threaded packing ring Titi, meshes with the internally disposed threads of collar 31.

Displaceably mounted within the bore 20 of T 16, as part of the actuator assembly 18, is an elongated actuator tube 32, rl`he outer end of actuator tube 32 has secured thereto a circular disc 34 which is maintained in such position by sleeves 36 and 38, both of which are secured to the exterior of such tube. Sleeve 3S is externally threaded, or the like, as at dit for mating with complementary internally formed threads 42, or the like, of cap d4. This cap 44 serves to protect a valve, or stopper illustrated schematically and designated generally by numeral 46. Thus, the valve assembly 46 may embrace a modied standard auto tire valve substantially as illustrated. Upon the withdrawal of cap 44, the outer end of sleeve 38 may then be coupled to a suitable air pressure supply either through a valve assembly or by removal of stopper assembly 46, as the case may be, for the purpose of expanding an expansible cell-collecting element to be described shortly. By suitably grasping disc 34 and cap 44, the actuator tube 32 may be inserted further into and retracted with respect to the T 16 for purposes that will be evident from the following. A crank 48 is suitably mounted at the periphery of disc 34 and extends away from the T 16 to facilitate the rotation of Vdisc 34, and thusly impart a rotational movement to the actuator tube 32.

The inner end of actuator tube 32 suitably mounts an elonoated tube 5t) possessing a certain degree of flexibility and resiliency. The other end of this tube 50 is asf sociated with a cell-collecting mandrel assembly 51, and, accordingly, is mounted over one end of a bored hub 52 which, additionally, threadedly supports a collar 54. Hub 52 has xed interiorly thereto, by means of a set screw 55 for example, a mandrel 56 which projects beyond this hub as Well as into tube 50 for purposes of rendering mandrel assembly 51 displaceable with tube 32 without causing undesirable twisting and failure 'of tube Si?. To this end, the inner end of mandrel 56 is xed to tube 32, as by silver brazing or soldering it to the interior of tube 32. The outer end of mandrel 56 may include an internally threaded chuck S5 for mounting an abrader element, for particular applications, Vof the type disclosed in my patent application identified below. If desired, and necessary for effective cell collection, depending upon the particular body passage to be scaried,

this mandrel 56 may possess a set which will normally extend the mandrel at an angle from the longitudinal axis defined by the solid line representation of this mandrel. For more particulars of this set, and structural Y abrading element 62.

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details enabling one skilled in the art to fabricate such mandrels, as well as abraders usable with the present invention, reference is made to applicants co-pending patent application Serial No. 556,182, tiled December 29, 1955, now Patent No. 2,955,592, of which this application forms a continuation-in-part.

As will be apparent from FIGS. 1 and 5, the relative proportionment of the various parts should be such that when the actuator'tube 32 is in a retracted position, as illustrated in FIG. 5, the mandrel 56 and projecting nozzle or chuck 58 will be withdrawn within the contines of the tubular sheath 12. In this position, the Vtubular sheath 12 mayV then be inserted into the selected body orifice or passage by employing the leading end thereof which bears member 14. In this connection, to facilitate such insertion of this end of sheath 12, a gelatin capsule, shown in phantom in FIG. 5 and there designated by numeral 60, may be telescoped over such end to minimize sharp edges and readily by-pass any obstruction that may Y be encountered. Naturally, this capsule will be of the type that'is easily dissolved by the body and capable of being forced oi the leading end of sheath 12 by simply initiating the longitudinal displacement of actuator tube 32 after the sheath 1,2 is in the selected body orifice or passage :for the desired distance. As will be described shortly, a cell-collecting element is positioned around the mandrel 56 prior to insertion to facilitate the collection of cell samples from the body tissure. Thus, when the actuator tube 32 is inserted further into the bore 20 of T 16, the mandrel 56 and associated parts will project out of the passage of the leading end of sheath 12. Once the sheath 12 is in the selected body orifice, the actuator assembly 18, tube 50 and cell-collecting mandrel assembly 51 can be retracted and totally withdrawn from the ing ring 30 from T 16. Under such circumstances, different probing or cell-collecting apparatus can then be` eiectively inserted through the passageway aiorded by sheath 12 to eiect other cell-collecting and exploratory techniques. On the other hand, it may be desired to simply change or alter the selected cell-collecting element of the cell-collecting assembly 51 to more effectively accomplish the results desired. Furthermore, after the gelatin capsule 60 has been discarded in the body pass-age, it may be necessary to either aspirate or dilate the passage walls to assure the collection of proper cell samples byV the cell-collecting element. In this connection, a pressure dierential source may be coupled to the nipple 24 of TV 16 for aspiration or dilation purposes as the case may be.

One form of cell-collecting element or abrader 62 is illustrated in section in FIG. 7 and is of the expansible type. This cell-collecting element 62 may conveniently embrace a distensible hollow cylindrical mounting 64 closed at one end and formed with a neck portion or opening communicating with its interior. That opening advantageously accommodates the mandrel assembly S1 or its functional equivalent. If desired, the neck portion may be constricted; but nevertheless, this neck portion is aixed to hub 52 by turning collar 54 relative to the hub, by means of the intermeshed thread, to prevent the mounting 64 from displacing longitudinally with respect to the mandrel assembly.

Since it is preferred, under most contemplated conditions Vof use, that the cell-collecting element 62 be of the disposable type, this cell-collecting element 62 should ernbody afconstruction formed at minimum cost. Thus, if there is a likelihood of rupture as the abrading element 62 is expanded, au expansible core 65 should be employed. This core, like element 62, is closed at one end and open at the other, and is telescoped over the projecting end of mandrel 56 to be ultimately disposed within This core 65 functions to evenly distribute pressure to the walls of the abrading element 62 when it is desired to expand the latter. The core 65 is secured against undesirable displacement with respect to mandrel 56, as for example by means of nylon threads 66 and 67, which embrace core 65, over conveniently located grooves in hub 52 and chuck 5S, respectively.V

Scarifying, collecting and retaining structures are associated with the mounting 64 preferably in the form of strands, tufts or bristles 6?. VThese bristles 63, as illustrated, may be arranged in the form of groups and may be relatively short and sti. VThe bristles 68 may be fabricated from nylon or catgut or any other suitable material employed for such purposes, with the employment of catgut desirable under certain conditions because of its absorbable nature when in the body. The inflatable mounting 64, on the other hand, as well Vas core 65, may

be formed from natural or artificial rubber or resinous material. Obviously, when the cell-collecting element62 is inflated, its bristles 68, when wiped across a tissue surface, will remove and retain a Vcertain number of cells. In this connection, the wiping maybe facilitated by rotating the cell-collecting element 62 through the interconnecting mechanism upon the rotation of handle 48 about the axis of the actuator tube 32.

In FIG. 8 another form of cell-collecting element'7 is illustrated and is substantially similar to element 62 in that it comprises a mounting 72 and laterally extending groups of bristles 74. However, this cell-collecting ele` ment 76 need not be of the expansible type and, consequently, may have both of its ends open and communicating with its interior. In addition, core 65 need not be utilized. The inherent elasticity of the material employed for the mounting 72 cooperates with collar 54 in aitlxing the abrader to the mandrel assembly 51. In this connection, the mounting l2 is conveniently constructed to provide a iirm engagement and gripping action with respect to the exposed faces of hub 52 and'to the interior of collar 54, thereby preventing any undesirable displacement of cell-collecting element 70 during use.

Referring now to FIG. 9, it will be observed that the free ends of bristles 76, which extend laterally from their` mounting 78, Vwhether of the inilatable or non-iniiatable type, may be beveled to more eectively assure the collection of a sucient number of cell samples. Naturally, other such techniques may be employed in an effort to increase the cell-collecting potential of a cell-collecting element contemplated by the present invention. Accordingly, a normal, positive or negative bristle end may be employed with respect to the contemplated direction of cutting or scarifying action, as will be understood by those familiar with the art of bristles. Y

Thus, the foregoing brush-type cell-collecting elements may be effectively employed for collecting samples of cells of the tissues that they scrape or scarify, not only at an initial location where the brush is brought into engagement therewith but those cell samples from tissues that they traverse as a result of the rotation of handle 48. In this manner, a physician will be assured that a general evaluation of cells is being achieved rather than merely a limited zone sampling.

Subsequent to the introduction of the sheath 12 and its 'enclosed mechanism and collection of the desired cell samples, the actuator tube 32 will then be retracted with respect to this sheath 12, obviously after the deilation of cell-collecting element 62, if of the inilatable type. This deilation can naturally be accomplished by decreasing the pressure within the mounting 64 by exposing the bore of sleeve 3S to the ambient air. This retraction of actuator tube 32 will cause the cell-collecting element of the mandrel assembly 51 to be withdrawn within the sheath 12. At this time, either the entire instrument may be withdrawn from the body passage or simply the cell-collecting element, by uncoupling the collar 31 with respect to the T 16. The latter procedures enables the physician to employ a fresh and unused cell-collecting element to obtain further cell samples of the selected tissue area.

Obviously, the mandrel 56 need not be of similar construction to that illustrated in the aforementioned application, but may be ofthe type that is slightly iiexible Without possessing a predetermined set which will dispose it obliquely or at an angle when it is projected from its associated end of sheath 12.

Thus, among others, the several objects of the invention 4as specically aforenoted are most eiectively achieved. Obviously, numerous changes in construction and rearrangement of parts may be resorted to Without departing from the spirit of the invention as defined by the appended claims.

I claim:

1. A diagnostic instrument of the character described, including in combination an elongated flexible tubular member having a longitudinally extending bore therethrough and adapted to be introduced into a body passage, an actuating assembly adjacent one end of said member, a cell-collecting assembly having scarifying means for removing cells from tissue membranes of said body passage Vand being adjacent the opposite end of said member, first means Within the tubular member for coupling said actuating assembly and said cell-collecting assembly, said first means being longitudinally slidable in and rotatably mounted with respect to said tubular member, said actuating assembly including second means cooperable with a resulting pressure differential source for selectively facilitating the dilation and aspiration of the body passage, the bore of said member extending to a location adjacent said opposite end adapted to communicate with the body passage, said second means having `a bore communicating with the bore of said member, said actuating assembly including means coupled with said rst means for rotating said cell-collecting assembly relative to said member, said actuating assembly further including means for shifting said rst means relative to said member to retract said cell-collecting assembly Within and projecting it beyond said member, said cell-collecting assembly comprising a longitudinally extending mandrel, said scarifying means surrounding said mandrel, said scarifying means including a disposable expansible hollow cylindrical member open at one end and closed at the other end, and said cellcollecting assembly further including an expansible core member disposed over portions of said mandrel and being within said cylindrical member, said cylindrical member being removably mounted on said core member, said rst means having an air passage communicating with said core member and means for coupling the air passage to a source of air pressure to thereby connect said core member with a source of air pressure to expand said cylindrical member.

2. The invention in accordance with claim 1 wherein said scarifying means includes bristles extending radially from said cylindrical member, said bristles being formed in spaced groups on said cylindrical member, and at least one bristle of at least one group having its free end beveled.

3. The invention in accordance with claim 2 wherein the free ends of all of the bristles of each one of said groups being beveled and defining a plane disposed at an angle with respect to the radially extending longitudinal axes of the bristles having their ends beveled.

References Cited in the file of this patent UNITED STATES PATENTS 1,127,948 Wappler Feb. 9, 1915 1,658,706 Carrott Feb. 7, 1928 1,926,223 Albera SeptA 12, 1933 1,995,196 Wolf Mar. 19, 1935 2,022,065 Wappler Nov. 26, 1935 2,701,559 Cooper Feb. 8, 1955 2,739,585 Ayre Mar. 27, 1956 2,955,591 MacLean Oct. 11, 1960 

1. A DIAGNOSTIC INSTRUMENT OF THE CHARACTER DESCRIBED, INCLUDING IN COMBINATION AN ELONGATED FLEXIBLE TUBULAR MEMBER HAVING A LONGITUDINALLY EXTENDING BORE THERETHROUGH AND ADAPTED TO BE INTRODUCED INTO A BODY PASSAGE, AN ACTUATING ASSEMBLY ADJACENT ONE END OF SAID MEMBER, A CELL-COLLECTING ASSEMBLY HAVING SCARIFYING MEANS FOR REMOVING CELLS FROM TISSUE MEMBRANES OF SAID BODY PASSAGE AND BEING ADJACENT THE OPPOSITE END OF SAID MEMBER, FIRST MEANS WITHIN THE TUBULAR MEMBER FOR COUPLING SAID ACTUATING ASSEMBLY AND SAID CELL-COLLECTING ASSEMBLY, SAID FIRST MEANS BEING LONGITUDINALLY SLIDABLE IN AND ROTATABLY MOUNTED WITH RESPECT TO SAID TUBULAR MEMBER, SAID ACTUATING ASSEMBLY INCLUDING SECOND MEANS COOPERABLE WITH A RESULTING PRESSURE DIFFERENTIAL SOURCE FOR SELECTIVELY FACILITATING THE DILATION AND ASPIRATION OF THE BODY PASSAGE, THE BORE OF SAID MEMBER EXTENDING TO A LOCATION ADJACENT SAID OPPOSITE END ADAPTED TO COMMUNICATE WITH THE BODY PASSAGE, SAID SECOND MEANS HAVING A BORE COMMUNICATING WITH THE BORE OF SAID MEMBER, SAID ACTUATING ASSEMBLY INCLUDING MEANS COUPLED WITH SAID FIRST MEANS FOR ROTATING SAID CELL-COLLECTING ASSEMBLY RELATIVE TO SAID MEMBER, SAID ACTUATING ASSEMBLY FURTHER INCLUDING MEANS FOR SHIFTING SAID FIRST MEANS RELATIVE TO SAID MEMBER TO RETRACT SAID CELL-COLLECTING ASSEMBLY WITHIN AND PROJECTING IT BEYOND SAID MEMBER, SAID CELL-COLLECTING ASSEMBLY COMPRISING A LONGITUDINALLY EXTENDING MANDREL, SAID SCARIFYING MEANS SURROUNDING SAID MANDREL, SAID SCARIFYING MEANS INCLUDING A DISPOSABLE EXPANSIBLE HOLLOW CYLINDRICAL MEMBER OPEN AT ONE END AND CLOSED AT THE OTHER END, AND SAID CELLCOLLECTING ASSEMBLY FURTHER INCLUDING AN EXPANSIBLE CORE MEMBER DISPOSED OVER PORTIONS OF SAID MANDREL AND BEING WITHIN SAID CYLINDRICAL MEMBER, SAID CYLINDRICAL MEMBER BEING REMOVABLY MOUNTED ON SAID CORE MEMBER, SAID FIRST MEANS HAVING AN AIR PASSAGE COMMUNICATING WITH SAID CORE MEMBER AND MEANS FOR COUPLING THE AIR PASSAGE TO A SOURCE OF AIR PRESSURE TO THEREBY CONNECT SAID CORE MEMBER WITH A SOURCE OF AIR PRESSURE TO EXPAND SAID CYLINDRICAL MEMBER. 